FDA Medical Device Recalls (openFDA)
Insulet Corporation: Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
- Recall number
- Z-2165-2020
- Recalling firm
- Insulet Corporation
- Product
- Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
- Status
- Terminated
- Initiated
- 2020-04-02
- Posted
- not on file
- Terminated
- 2021-09-14
- Reason
- After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
- Root cause
- Device Design
- Action
- URGENT: Field Safety Notification letters dated 4/3/20 were sent to customers. How do users prevent this from happening? This issue is entirely preventable (see Figure 1 below) by (1) always entering the Bolus Calculator through the Bolus Button from the Home screen and (2) by never entering the Bolus Calculator through the Menu Icon. Is it safe for users to continue using the Omnipod DASH" PDM? Yes, it is safe for users to continue using the Omnipod DASH" PDM if the steps detailed above are followed to avoid incorrect bolus calculations. Users will not experience the issue if they always use the Bolus Calculator by entering through the Bolus Button on the Home screen. How will Insulet fix the software issue? A software update is being made to fix this issue, along with the issue described in the February 2020 notice and an updated replacement Omnipod DASH" PDM will be provided from August 2020. Once available, we will contact users directly via email or letter to arrange shipping. If you have received an email from Insulet providing you with the information covered in this letter and you have already responded, you do not need to do anything more at this time. If you have not received an email, we would ask that you go our website to confirm receipt of this letter and provide the Serial Number of your Omnipod DASH" PDM to ensure a replacement is reserved for you. If you would like additional information, our Customer Care is available 24/7 on 0800 011 6132 (+44 (0) 203 887 1709 when calling from abroad) or by email omnipod-GB@insulet.com.
- Quantity
- 1773
- Distribution
- The products were distributed to the following foreign countries: Italy, Netherlands, UK.
- Lot, serial or model codes
- UDI: PT000011 10385082000146; Lot Numbers: L000200, L000201, L000203, L000209, L000210
- 510(k) numbers
- ["K192659"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3014585508
- Firm city
- Acton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28